Revisiting the Justification of Trademark Protection for Single Drug Compositions: A Critical Analysis from a Regulatory Perspective

Trademarks, which are premised on product differentiation, are alleged to play a divergent role when used on pharmaceutical products: they tend to create an artificial product differentiation for the bioequivalent pharmaceutical products that are marketed as branded, generics, and branded-generic products. It is implied that the companies incorporate trademarks to market their products to different consumers at different prices. However, concerns arise when a company uses multiple trademarks for a single active pharmaceutical ingredient (API); sometimes, the company labels each trademark as treating a different medical condition. This practice of brand proliferation may pose risks to patient safety by confusing patients and health care providers, which can lead to double dosing the drug. Simultaneously, it may also promote artificial product differentiation, allowing few companies to regulate the market for certain treatments without offering any therapeutic difference. Such differentiation is not restricted merely to the branded products, but it is also present in branded-generics, brands of the same formulation marketed by a single company. The magnitude of such differentiation has been observed by the legal scholars and regulatory authorities in different jurisdictions from consumers’ safety and the competition perspective. These pharma company practices raise questions on trademark use and regulation for medicinal products and the trademark’s consequences on consumer safety and market competition. In this context, this paper aims to analyze legal scholars’ views on the use of pharmaceutical product trademarks and the policy interventions toward regulating the use of multiple trademarks by one company for the bioequivalent medicinal products

Judicial Navigation of Drug Name Regulation in India

Almost two decades back the Supreme Court of India while deciding the trademark disputes related to pharmaceutical products raised serious concerns towards the medicines sold under unregulated similar proprietary names. Thereby the judiciary issued directions to the drug regulatory authority for drug name regulation. However, since then in the absence of a definite regulatory structure, the judiciary has continued navigating the scope of India’s drug name regulation. In this context, the article reflects upon the judicial attempts for integrating drug-name regulations in the current regulatory structure, while critically analyzing the judiciary-backed recent amendments in the Drugs and Cosmetics Rule, 1945

Judicial Navigation of Drug Name Regulation in India

269-276Almost two decades back the Supreme Court of India while deciding the trademark disputes related to pharmaceutical products raised serious concerns towards the medicines sold under unregulated similar proprietary names. Thereby the judiciary issued directions to the drug regulatory authority for drug name regulation. However, since then in the absence of a definite regulatory structure, the judiciary has continued navigating the scope of India’s drug name regulation. In this context, the article reflects upon the judicial attempts for integrating drug-name regulations in the current regulatory structure, while critically analyzing the judiciary-backed recent amendments in the Drugs and Cosmetics Rule, 1945